Assessment of Myocardial Disease in Man Using Novel Non-invasive Diagnostic Tools
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- To validate the diagnostic ability of the two devices against echo and clinical data as the "gold standard".
研究概览
简要总结
This study will be testing two devices which are designed to detect cardiovascular disease in patients as early as possible. As there are now many therapies to prevent and treat this condition it is believed that detecting it early will help reduce the burden of the disease and permit more effective treatment.
The two devices the investigators are testing are the ViScope developed by HD Medical and a device developed by CSIRO. Both of these devices are simple, non-invasive and may provide useful information on how well the heart contracts and relaxes as well as valve function of the heart.
The investigators are planning to enroll 100 healthy subjects, 100 participants with risk factors for heart failure and 300 patients with varying types of heart failure.
The data collected from the experimental devices will be compared to the results from standard tests.
Patients will not have any of their therapies altered as part of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years
- •Have provided consent
- •Risk factor patients also require:
- •Hypertension > 2 years
- •Diabetes > 2 years
- •Known ischemia, TIA, or stroke
- •Arrhythmia; or reduced renal function (eGFR<50 ml/min)
- •Heart Failure patients also require:
- •LVEF <40%
- •Receiving standard medication for the treatment of symptomatic systolic heart failure with an NYHA Class of II-IV.
排除标准
- •Health patients (must not have any of the following):
- •Cardiovascular disease
- •Receiving cardiovascular medication
- •Not in normal sinus rhythm (also required for HF patients)
结局指标
主要结局
To validate the diagnostic ability of the two devices against echo and clinical data as the "gold standard".
时间窗: Day 1 (study day)
We will construct received operative characteristic (Roc) curves for sensitivity and specificity of the HD Medical ViScope and the CSIRO back scatter analysis device in detecting heart failure using echocardiogram and clinical data as the "gold standard".
次要结局
- Correlation of the devices with standard tests such as BP, HR and BNP.(Day 1 (study day))
研究者
Prof Henry Krum
Prof
Monash University